Pacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation

Plain-English summary

American Contract Systems, Inc. is recalling 24 units of various pacemaker packs and cardiothoracic surgical packs distributed to health systems and medical device distributors across the United States, including Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

The recalled packs were exposed to multiple sterilization cycles without validation that the sterilization process was appropriate for multiple exposures. This validation defect raises concerns about whether the devices maintain the sterility and safety standards required for implantable and surgical applications.

Health systems and distributors who received these products should identify and quarantine the affected units using the provided lot and serial numbers, then contact American Contract Systems for instructions on return, replacement, or destruction. The products should not be used in any implantation or surgical procedures.

Patients who have undergone procedures or received implants using these recalled packs should contact their healthcare provider for guidance, although the FDA has not reported any illnesses or injuries associated with this recall.

The recalled product

Product

Various Pacemaker Packs, Cardio Thoracic Packs

Manufacturer

American Contract Systems, Inc.

Category

Medical Device — Cardiac and Surgical Packs

Hazard

• improper-sterilization
• validation-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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